Waters Integrates Advanced Technology for Enhanced Quality Control of Biologics
Waters Corporation, a renowned leader in analytical instruments, has taken a significant step forward in the field of biopharmaceutical quality control by integrating multi-angle light scattering (MALS) detectors with its Empower™ Software. This advancement, announced on May 7, 2025, aims to enhance the efficiency of quality control processes for biological products, ensuring that they meet stringent regulatory standards.
The new feature allows the Empower™ Software to support the acquisition of critical biological data, enabling laboratories to perform quality control (QC) analysis more effectively. This integration not only broadens the capabilities of biopharmaceutical labs but also simplifies the digital footprint necessary for acquiring and submitting compliant data to regulatory authorities. With this development, clients can potentially save up to six months on software validation time, a crucial benefit in the competitive biopharmaceutical landscape.
The Empower™ Software is widely recognized as the industry's most robust and compliant chromatography data system (CDS), utilized globally for submitting over 80% of new drug data to regulatory bodies. The introduction of MALS technology enhances QC for biotherapeutic products by improving efficiency and compliance with good manufacturing practices (GMP). This latest feature reduces the need for extensive user training in compliant environments, making it user-friendly and accessible.
Dr. Udit Batra, CEO of Waters Corporation, emphasized this commitment, stating, "The launch of Empower multi-angle light scattering detectors showcases our dedication to integrating advanced analytical technologies into our Empower CDS ecosystem since acquiring Wyatt Technology." He highlighted the unique capability of MALS technology to detect high molecular weight species that other detectors may overlook, thereby minimizing the risk of erroneous quality control results for biotherapeutics.
By combining reliable software with sophisticated analytical light scattering instrumentation, Waters provides its clients with a unified solution that enhances data accuracy and productivity. This integration supports high-volume quality control testing, critical for ensuring the safety and efficacy of life-saving biological therapies for patients.
The MALS technology, enriched by Empower Software, allows for comprehensive measurement of essential quality attributes in peptides and proteins in a single analytical pass. As a result, this can lead to a 20% reduction in analysis time and provide earlier insights into the stability, safety, and efficacy of biological products. William Wittbold, Senior Operations Director at Pace Analytical, expressed confidence in the integration, asserting that MALS combined with Empower will improve service offerings in their contract development and manufacturing organization (CDMO) operations. He noted, "Detailed MALS data is crucial for understanding complex biotherapies. Coupled with the reliability of Empower Software, we believe this integration offers exceptional value to our clients, ensuring drug development partners achieve the highest quality outcomes."
The integration of DAWN™, miniDAWN™, and OptiLab™ detectors with Empower Software is expected to be available for peptide and protein workflows by July 2025. This innovation addresses the challenges faced by labs in managing and validating biologics data, ultimately contributing to the mission of Waters Corporation to enhance the effectiveness of medications, ensure food safety, and maintain water purity worldwide.
In summary, Waters Corporation's latest advancements in Empower Software represent a significant stride toward improving the quality control processes essential for biopharmaceuticals. With a commitment to integrating advanced technologies, Waters aims to facilitate compliance and enhance laboratory efficiency, all while continuing to prioritize patient safety and product integrity. For further details on this integration with MALS technology, please visit their product page or follow Waters on their social media channels.
The new feature allows the Empower™ Software to support the acquisition of critical biological data, enabling laboratories to perform quality control (QC) analysis more effectively. This integration not only broadens the capabilities of biopharmaceutical labs but also simplifies the digital footprint necessary for acquiring and submitting compliant data to regulatory authorities. With this development, clients can potentially save up to six months on software validation time, a crucial benefit in the competitive biopharmaceutical landscape.
The Empower™ Software is widely recognized as the industry's most robust and compliant chromatography data system (CDS), utilized globally for submitting over 80% of new drug data to regulatory bodies. The introduction of MALS technology enhances QC for biotherapeutic products by improving efficiency and compliance with good manufacturing practices (GMP). This latest feature reduces the need for extensive user training in compliant environments, making it user-friendly and accessible.
Dr. Udit Batra, CEO of Waters Corporation, emphasized this commitment, stating, "The launch of Empower multi-angle light scattering detectors showcases our dedication to integrating advanced analytical technologies into our Empower CDS ecosystem since acquiring Wyatt Technology." He highlighted the unique capability of MALS technology to detect high molecular weight species that other detectors may overlook, thereby minimizing the risk of erroneous quality control results for biotherapeutics.
By combining reliable software with sophisticated analytical light scattering instrumentation, Waters provides its clients with a unified solution that enhances data accuracy and productivity. This integration supports high-volume quality control testing, critical for ensuring the safety and efficacy of life-saving biological therapies for patients.
The MALS technology, enriched by Empower Software, allows for comprehensive measurement of essential quality attributes in peptides and proteins in a single analytical pass. As a result, this can lead to a 20% reduction in analysis time and provide earlier insights into the stability, safety, and efficacy of biological products. William Wittbold, Senior Operations Director at Pace Analytical, expressed confidence in the integration, asserting that MALS combined with Empower will improve service offerings in their contract development and manufacturing organization (CDMO) operations. He noted, "Detailed MALS data is crucial for understanding complex biotherapies. Coupled with the reliability of Empower Software, we believe this integration offers exceptional value to our clients, ensuring drug development partners achieve the highest quality outcomes."
The integration of DAWN™, miniDAWN™, and OptiLab™ detectors with Empower Software is expected to be available for peptide and protein workflows by July 2025. This innovation addresses the challenges faced by labs in managing and validating biologics data, ultimately contributing to the mission of Waters Corporation to enhance the effectiveness of medications, ensure food safety, and maintain water purity worldwide.
In summary, Waters Corporation's latest advancements in Empower Software represent a significant stride toward improving the quality control processes essential for biopharmaceuticals. With a commitment to integrating advanced technologies, Waters aims to facilitate compliance and enhance laboratory efficiency, all while continuing to prioritize patient safety and product integrity. For further details on this integration with MALS technology, please visit their product page or follow Waters on their social media channels.
Topics Health）
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